Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E)

GUDID 00815568020939

Labelled with CE mark

KOBOLD, LLC

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00815568020939
• NIH Device Record Key: a5a72d43-c143-4d87-bd74-0525836fa03d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E)
• Version Model Number: 707-001
• Company DUNS: 014292258
• Company Name: KOBOLD, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Angle: 60 degree
• Angle: 60 degree
• Angle: 60 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815568020939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142330

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00815568020939]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-02
• Device Publish Date: 2019-03-25

On-Brand Devices [Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E)]

• 00815568020038: 707-001
• 00815568020939: Labelled with CE mark